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Status unknownNCT05650151Updated Dec 14, 2022

Peri-operative Vitamin D Therapy for Hepatectomy

An interventional study of Vitamin D and Placebo in Vitamin D Deficiency, Hepatocellular Carcinoma and Perioperative Complication, sponsored by National Taiwan University Hospital. Status unknown. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The goal of this double-blind, randomized controlled trial is to test the effect of short-term and high-dose vitamin D therapy in patients undergoing hepatectomy for hepatocellular carcinoma.

Read the detailed description

Participants will receive short-term high dose of vitamin D during perioperative period.

The main questions the study aims to answer are:

  1. If vitamin D therapy benefits perioperative care
  2. If short-term high dose of vitamin D supplement is safe
02

Conditions studied

  • Vitamin D Deficiency
  • Hepatocellular Carcinoma
  • Perioperative Complication

Keywords

  • Vitamin d therapy
  • Hepatocellular Carcinoma
  • Perioperative Complication
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 200 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients older than 20 years
  • Patients will undergo hepatectomy for hepatocellular carcinoma.

Exclusion criteria

Exclusion Criteria:

  • Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Vitamin D group

    Dietary Supplement: Vitamin D

  • Placebo comparator
    Control group

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementVitamin D

    576 000 IU D 5-7 days prior to the surgery and 144 000 IU daily on post-operative day 1-2

  • Dietary supplementPlacebo

    An equal volume of medium chain triglyceride (MCT, as placebo) to vitamin D 5-7 days prior to the surgery and on the post-operative day 1-2.

06

What researchers measure

Primary outcomes

  1. Infection rate

    Diagnosed by clinical presentation and relevant biomarker

    Time frame: Perioperative period

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05650151
Lead sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Dec 14, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Jan 31, 2024 (estimated)
Last update
Dec 14, 2022

Study contacts

Yin-Yi Han, PHD
Contact
yyhan@ntuh.gov.tw
886972651405
Yin-Yi Han, PHD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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